CLOPIDOGREL KRKA D.D. 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Krka d.d. 75 mg Film-Coated Tablets EFG

clopidogrel

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Clopidogrel Krka d.d. is and what it is used for
2. What you need to know before you take Clopidogrel Krka

1. How to take Clopidogrel Krka

1. Possible side effects
2. Storing Clopidogrel Krka

1. Contents of the pack and other information

1. What Clopidogrel Krka d.d. is and what it is used for

Clopidogrel Krka d.d. contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that clump together to form blood clots. Antiplatelet agents prevent this clumping, reducing the risk of blood clots (a process called thrombosis).

Clopidogrel Krka d.d. is given to adults to prevent blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed Clopidogrel Krka d.d. to help prevent blood clots and reduce the risk of these serious events because:

• you have a condition that leads to hardening of the arteries (also known as atherosclerosis), and
• you have previously had a myocardial infarction, stroke, or suffer from a disease called peripheral arterial disease, or
• you have had a severe type of chest pain known as "unstable angina" or "myocardial infarction". For the treatment of this disease, your doctor may need to place a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots).

• you have an irregular heartbeat, a condition called "atrial fibrillation", and cannot take medicines known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of Clopidogrel Krka and acetylsalicylic acid for this disease. Your doctor will have prescribed Clopidogrel Krka d.d. plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before you take Clopidogrel Krka

Do not take Clopidogrel Krka d.d.

• if you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• if you have an active bleeding, such as a stomach ulcer or bleeding in the brain;
• if you have a severe liver disease.

If you think any of these apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Krka d.d.

Warnings and precautions

Before starting treatment with Clopidogrel Krka, inform your doctor if you are in any of the following situations:

• if you have a risk of bleeding because:

• you have a disease that involves a risk of internal bleeding (such as a stomach ulcer).

• you have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).

• you have recently had a severe injury.
• you have recently undergone surgery (including dental surgery).
• you are scheduled to undergo surgery (including dental surgery) in the next seven days.

• if you have had a blood clot in an artery of the brain (ischemic stroke) in the last 7 days.

• if you have liver or kidney disease.

• if you have had an allergy or reaction to any medicine used to treat your disease.

During treatment with Clopidogrel Krka d.d.:

• tell your doctor if you are scheduled to have surgery (including dental surgery).

• tell your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bleeding under the skin that can appear as red spots), accompanied by or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

• if you cut or injure yourself, bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the blood from forming clots. For minor cuts or injuries, such as cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").

• your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children as it is not effective.

Other medicines and Clopidogrel Krka

tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the use of Clopidogrel Krka or vice versa.

You must tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:
• • oral anticoagulants, medicines used to decrease blood clotting,

• non-steroidal anti-inflammatory drugs, medicines used to treat pain and/or inflammation of muscles or joints,

• heparin, or any other injectable medicine used to decrease blood clotting,

• ticlopidine, another antiplatelet agent,

• • a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of the same type), medicines used to treat depression,
• omeprazole or esomeprazole, medicines to treat stomach upset,

• fluconazole or voriconazole, medicines to treat fungal infections,
• efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,

• carbamazepine, a medicine to treat some forms of epilepsy,

• moclobemide, a medicine for depression,
• repaglinide, a medicine for diabetes,

• paclitaxel, a medicine to treat cancer,

• antiretrovirals (medicines to treat HIV infection).

If you have had severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Clopidogrel Krka d.d. in combination with acetylsalicylic acid, a substance found in many medicines used to relieve pain and reduce fever. A dose of acetylsalicylic acid given occasionally (not exceeding 1,000 mg in 24 hours) is generally not a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Krka d.d. with food and drinks

Clopidogrel Krka can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you must tell your doctor or pharmacist before taking Clopidogrel Krka d.d. If you become pregnant while taking Clopidogrel Krka, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

Do not breastfeed while taking this medicine.

If you are breastfeeding or plan to breastfeed, tell your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Clopidogrel Krka d.d. is unlikely to affect your ability to drive or use machines.

3. How to take Clopidogrel Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg Clopidogrel Krka d.d. tablet per day, taken orally, with or without food, and at the same time each day.

If you have had severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Clopidogrel Krka d.d. (4 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg Clopidogrel Krka tablet per day, as described above.

You should take Clopidogrel Krka d.d. for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Krka d.d. than you should

Contact your doctor or go to the nearest hospital emergency department, as there is a higher risk of bleeding.

If you forget to take Clopidogrel Krka

If you forget to take a dose of Clopidogrel Krka d.d., but remember before 12 hours have passed since the time you should have taken the medicine, take the tablet immediately and the next one at the usual time.

If you forget for more than 12 hours, simply take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel Krka d.d.

Do not stop your treatment unless your doctor tells you to. Contact your doctor or pharmacist before stopping this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Consult your doctor immediately if you experience:

• Fever, signs of infection, or extreme fatigue. These symptoms may be due to a rare decrease in some blood cells.

• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), associated with or without bleeding that appears under the skin as red spots and/or confusion (see section 2 "Warnings and precautions").

• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Krka is bleeding.

Bleeding may occur in the stomach or intestine, bruising, bleeding (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Krka

If you cut or injure yourself, it is possible that bleeding may take a little longer to stop. This is related to the mechanism of action of the medicine, as it prevents the blood from forming clots. For minor cuts or injuries, such as cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

Diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, tingling, or numbness.

Rare side effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in men.

Very rare side effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (e.g., general feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects with unknown frequency (cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

Your doctor may also observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Clopidogrel Krka d.d.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Clopidogrel Krka d.d. Composition

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).

• The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, crospovidone (type A), macrogol 6000, and hydrogenated castor oil in the tablet, and polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc, and macrogol 3000 in the film coating.

Appearance of Clopidogrel Krka d.d. and Container Content

Film-coated tablets are pink, round, and slightly convex.

Boxes of 7, 14, 28, 30, 50, 56, 84, 90, and 100 film-coated tablets in blisters.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu/.